Long-term Follow-up of Broad Spectrum Human Papillomavirus (HPV) Vaccine Study in Women (V503-021)
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|ClinicalTrials.gov Identifier: NCT02653118|
Recruitment Status : Active, not recruiting
First Posted : January 12, 2016
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment|
|Cervical Cancer Vulvar Cancer Vaginal Cancer Genital Warts Human Papillomavirus Infection||Biological: V503 Biological: GARDASIL|
|Study Type :||Observational|
|Estimated Enrollment :||4453 participants|
|Official Title:||A Registry-Based Extension of Protocol V503-001 in Countries With Centralized Cervical Cancer Screening Infrastructures to Evaluate the Long-Term Effectiveness, Immunogenicity, and Safety of Multivalent Human Papillomavirus (HPV) L1 Virus- Like Particle (VLP) Vaccine as Administered to 16- to 26- Year- Old Women|
|Actual Study Start Date :||January 22, 2016|
|Estimated Primary Completion Date :||January 1, 2024|
|Estimated Study Completion Date :||January 1, 2024|
Cohort 1: V503 in the Base Study
Participants received the selected dose formulation of V503 (0.5 mL in a 3-dose regimen) from a Denmark, Norway, or Sweden site in the base study (V503-001, NCT00543543). No study vaccination will be administered in study V503-021.
Cohort 2: GARDASIL in the Base Study
Participants received GARDASIL (0.5 mL in a 3-dose regimen) from a Denmark, Norway, or Sweden site in the base study (V503-001, NCT00543543) and were offered the selected dose formulation of V503 (0.5 mL in a 3-dose regimen) at the conclusion of the base study. V503 vaccination was voluntary and not a condition for inclusion in Cohort 2. No study vaccination will be administered in study V503-021.
- Combined Incidence of HPV Type 16, 18, 31, 33, 45, 52, or 58-related Cervical Intraepithelial Neoplasia (CIN) Grades 2 or 3, Adenocarcinoma In Situ (AIS), and Cervical Cancer [ Time Frame: Up to 16 years after vaccination in V503-001 base study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653118
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|